Bard Abg 100 Intravascular Oxygen Monitor System
FDA 510(k) K884063 · C.R. Bard, Inc.
510(k) numberK884063
Submission
- Device name
- Bard Abg 100 Intravascular Oxygen Monitor System
- Applicant
- C.R. Bard, Inc.
Tewksbury, MA, US - Received
- September 26, 1988
- Decision date
- December 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1200
- Specialty
- Anesthesiology
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Questions and answers
When was Bard Abg 100 Intravascular Oxygen Monitor System cleared by the FDA?
Bard Abg 100 Intravascular Oxygen Monitor System (K884063) received a 510(k) decision of Substantially Equivalent on December 16, 1988, 81 days after the submission was received.
What is the product code of K884063?
The FDA product code is CCE – Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling, a Class II (moderate risk) device regulated under 21 CFR 868.1200.